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Compares treatment options for Ureteral Stent-Related Symptoms
Official title ComfiJ Versus Conventional Double-J Stent for Ureteral Stent Symptoms
ClinicalTrials.gov ID: NCT07627828
What this study is testing
- What it's testing
- This prospective multicenter randomized controlled trial will compare stent-related symptoms after placement of a ComfiJ ureteral stent versus a conventional double-J ureteral stent in adult patients undergoing unilateral ureteroscopy or retrograde intrarenal surgery for urinary stones when short-term postoperative ureteral stenting is clinically indicated. Eligible patients will be randomized intraoperatively after the operating surgeon confirms the need for postoperative stenting.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 to 80 years.
- Adult patients undergoing unilateral ureteroscopy or retrograde intrarenal surgery for ureteric or renal stones.
- Intraoperative confirmation that short-term postoperative ureteric stenting for approximately 2 weeks is clinically indicated.
- Indications for postoperative stenting may include ureteric edema, minor ureteric mucosal trauma, need for ureteric dilatation, ureteral access...
- Ability to understand and complete the Arabic Ureteral Stent Symptom Questionnaire.
You likely can't join if
- Cases in which no postoperative ureteric stent is clinically indicated.
- Cases requiring prolonged urinary drainage or major reconstructive decision-making.
- Bilateral ureteroscopy or retrograde intrarenal surgery.
- Solitary kidney.
- Major ureteric injury or ureteric perforation.
- Preoperative febrile urinary tract infection or sepsis.
See the full eligibility criteria
- Age 18 to 80 years.
- Adult patients undergoing unilateral ureteroscopy or retrograde intrarenal surgery for ureteric or renal stones.
- Intraoperative confirmation that short-term postoperative ureteric stenting for approximately 2 weeks is clinically indicated.
- Indications for postoperative stenting may include ureteric edema, minor ureteric mucosal trauma, need for ureteric dilatation, ureteral access sheath use with expected postoperative edema, impacted stone, residual dust...
- Ability to understand and complete the Arabic Ureteral Stent Symptom Questionnaire.
- Ability to provide written informed consent.
- Cases in which no postoperative ureteric stent is clinically indicated.
- Cases requiring prolonged urinary drainage or major reconstructive decision-making.
- Bilateral ureteroscopy or retrograde intrarenal surgery.
- Solitary kidney.
- Major ureteric injury or ureteric perforation.
- Preoperative febrile urinary tract infection or sepsis.
- Pregnancy or breastfeeding.
- Neurogenic bladder.
- Overactive bladder syndrome.
- Major neurological disease or psychiatric disease affecting symptom reporting.
- History of major bladder, prostate, or pelvic surgery likely to confound stent-related symptoms.
- Concomitant use of alpha-blockers, anticholinergics, chronic analgesics, or other medications likely to alter symptom evaluation.
- Other acute medical conditions that might influence the Ureteral Stent Symptom Questionnaire pain score, including acute pancreatitis, acute gastroenteritis, or musculoskeletal disorders.
- Known allergy to any study-related medication or device material.
- Inability to comply with the follow-up schedule.
The study team makes the final eligibility decision.
Where it's taking place
- Banī Suwayf, Beni Suweif Governorate, Egypt
- Minya, Egypt
- Tanta, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Banī Suwayf, Beni Suweif Governorate, Egypt; Minya, Egypt; Tanta, Egypt. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.